Blog
RSS FeedPosted by Michael Wonder on 31 Mar 2025
Imfinzi approved in the US as first and only peri-operative immunotherapy for patients with muscle-invasive bladder cancer
31 March 2025 - Based on NIAGARA Phase 3 trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 31 Mar 2025
Lilly’s statement about the CHMP opinion issued for donanemab
28 March 2025 - The EMA's CHMP issued an opinion that does not recommend Eli Lilly's donanemab be granted marketing ...
Posted by Michael Wonder on 30 Mar 2025
Bristol Myers Squibb receives positive CHMP opinion for peri-operative regimen of neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo for resectable non-small cell lung cancer in patients with tumour cell PD-L1 expression ≥1%
28 March 2025 - Recommendation based on Phase 3 CheckMate -77T trial showing significant event-free survival improvement when compared to neoadjuvant ...
Posted by Michael Wonder on 28 Mar 2025
Neurim Pharmaceuticals receives European marketing authorisation for paediatric prolonged-release melatonin (Slenyto) for the treatment of insomnia in children with ADHD
26 March 2025 - Neurim Pharmaceuticals announces that the European Commission has approved the extension of the indication to include ...
Posted by Michael Wonder on 27 Mar 2025
European Commission approves Merck’s Capvaxive (pneumococcal 21 valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults
26 March 2025 - EC decision marks the fourth approval for Capvaxive for pneumococcal vaccination in adults ...
Posted by Michael Wonder on 17 Mar 2025
Imfinzi approved in the EU as first and only immunotherapy for limited-stage small cell lung cancer
17 March 2025 - Approval based on ADRIATIC Phase 3 trial results which showed a 27% reduction in the risk ...
Posted by Michael Wonder on 17 Mar 2025
Bristol Myers Squibb receives approval from the European Commission to expand use of CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
14 March 2025 - In the TRANSCEND FL trial, 97.1% of patients responded to Breyanzi , with 94.2% of patients achieving ...
Posted by Michael Wonder on 12 Mar 2025
Geron announces European Commission approval of Rytelo (imetelstat), a first in class telomerase inhibitor, for the treatment of adults with transfusion-dependent anaemia due to lower risk MDS
11 March 2025 - Rytelo is the first and only telomerase inhibitor approved in the US and Europe. ...
Posted by Michael Wonder on 10 Mar 2025
Wainzua (eplontersen) approved in the EU for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy
10 March 2025 - Second major approval for Wainzua, which is marketed in the US as Wainua. ...
Posted by Michael Wonder on 07 Mar 2025
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma
7 March 2025 - Approval based on results of Phase 3 CheckMate-9DW clinical trial demonstrating a statistically significant and clinically ...
Posted by Michael Wonder on 03 Mar 2025
Imfinzi-based perioperative regimen recommended for approval in the EU by CHMP for resectable non-small cell lung cancer
3 March 2025 - Recommendation based on AEGEAN Phase 3 trial results which showed Imfinzi reduced the risk of recurrence, ...
Posted by Michael Wonder on 03 Mar 2025
Vertex receives CHMP positive opinion for expanded label for Kaftrio in combination with ivacaftor for people with cystic fibrosis to include rare mutations
28 February 2025 - If approved, approximately 4,000 people with cystic fibrosis in the European Union will be eligible for ...
Posted by Michael Wonder on 02 Mar 2025
Highlights from the 24-27 February 2025 CHMP meeting
28 February 2025 - Four new medicines recommended for approval; another 16 medicines recommended for extension of their therapeutic indications. ...
Posted by Michael Wonder on 02 Mar 2025
Krystal Biotech receives positive CHMP opinion for Vyjuvek for the treatment of dystrophic epidermolysis bullosa
28 February 2025 - EC approval decision anticipated in second quarter of 2025. ...
Posted by Michael Wonder on 01 Mar 2025
Valneva receives EMA’s positive CHMP opinion for adolescent label extension for chikungunya vaccine Ixchiq
28 February 2025 - If granted, Ixchiq will become the first vaccine against the chikungunya virus available in the EU ...